Prospective randomized controlled trial of traditional laparoscopic cholecystectomy versus single-incision laparoscopic cholecystectomy: report of preliminary data.

摘要

BACKGROUND: This study presents preliminary data from a prospective randomized multicenter, single-blinded trial of single-incision laparoscopic cholecystectomy (SILC) versus standard laparoscopic cholecystectomy (4PLC). METHODS: Patients with symptomatic gallstones, polyps, or biliary dyskinesia (ejection fraction <30%) were randomized to SILC or 4PLC. Data included operative time, estimated blood loss, length of skin and fascial incisions, complications, pain, satisfaction and cosmetic scoring, and conversion. RESULTS: Operating room time was longer with SILC (n = 50) versus 4PLC (n = 33). No differences were seen in blood loss, complications, or pain scores. Body image scores and cosmetic scores at 1, 2, 4, and 12 weeks were significantly higher for SILC. Satisfaction scores, however, were similar. CONCLUSIONS: Preliminary results from this prospective trial showed SILC to be safe compared with 4PLC although operative times were longer. Cosmetic scores were higher for SILS compared with 4PLC. Satisfaction scores were similar although both groups reported a significantly higher preference towards SILC.